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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04310930
Registration number
NCT04310930
Ethics application status
Date submitted
28/02/2020
Date registered
17/03/2020
Date last updated
8/08/2023
Titles & IDs
Public title
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
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Scientific title
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)
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Secondary ID [1]
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U1111-1209-0672
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Universal Trial Number (UTN)
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Trial acronym
FORMaT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease Due to Mycobacteria (Diagnosis)
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amikacin
Treatment: Drugs - Tigecycline
Treatment: Drugs - Imipenem
Treatment: Drugs - Cefoxitin
Treatment: Drugs - Azithromycin
Treatment: Drugs - Clarithromycin
Treatment: Drugs - Clofazimine
Treatment: Drugs - Ethambutol
Treatment: Drugs - Amikacin
Treatment: Drugs - Linezolid
Treatment: Drugs - co-trimoxazole
Treatment: Drugs - Doxycycline
Treatment: Drugs - Moxifloxacin
Treatment: Drugs - Bedaquiline
Treatment: Drugs - Rifabutin
Active Comparator: Intensive Therapy A - Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin AND clofazimine.
Experimental: Intensive Therapy B - Following Randomisation 1, Participants will receive inhaled amikacin (IA), IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin AND clofazimine.
Experimental: Intensive Therapy C - Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin.
Active Comparator: Consolidation A - Oral clofazimine + oral azithromycin/oral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.
Experimental: Consolidation B - Inhaled amikacin (IA), oral clofazimine + oral azithromycin/oral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.
Treatment: Drugs: Amikacin
Adults: Intravenous amikacin 5mg/kg once daily or 7.5mg/kg twice daily or 20-25 mg/kg thrice weekly. Children:Intravenous amikacin 15-30 mg/kg once daily, maximum dose 1500mg
Treatment: Drugs: Tigecycline
Adults: Intravenous Tigecycline 25 mg increasing by 5 mg every two doses until either maximum dose reached (50mg) or until patient is unable to tolerate twice daily. Children (=8 years of age) intravenous tigecycline: Day 1- 0.6mg/kg twice daily to a maximum of 25mg. Day 2- 0.6mg/kg (maximum 25mg) in the morning, 1.2 mg/kg (maximum 50mg) at night. Day 3- 1.2mg/kg (maximum 50 mg) twice daily
Treatment: Drugs: Imipenem
Adults: Intravenous Imipenem (=50kg) 500mg twice daily (<50kg) 15 mg/kg twice daily. Children: intravenous imipenem Day 1- 2- 25mg/kg (maximum 1g) twice daily. DAY 3- 25mg/kg (maximum 1g) four times daily (drop to 3 if not tolerated).
Treatment: Drugs: Cefoxitin
Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.
Treatment: Drugs: Azithromycin
Adults: Oral azithromycin 500mg (=40kg) once daily, (<40kg) 250mg once daily.During consolidaiton: 500mg (=40kg) thrice weekly, (<40kg) 250mg thrice weekly.
Children: Oral azithromycin:10mg/kg (maximum 500mg) once daily. During consolidation 10mg/kg once daily maximum 500mg.
Treatment: Drugs: Clarithromycin
Adult: If azithromycin is poorly tolerated use oral clarithromycin 500mg twice daily.Children: If azithromycin is poorly tolerated use oral clarithromycin. In children 1 month old- 11years of age the following dosing applies: <8kg: 7.5mg/kg twice daily, maximum dose 62.5mg, 8-11kg: 62.5mg twice daily, maximum dose 62.5mg, 12-19 kg: 125mg twice daily, maximum dose 125mg, 20-29 kg: 187.5mg twice daily, maximum dose 187.5mg, 30-40 kg: 250mg twice daily, maximum dose 250mg, Children 12-18 years of age: 500 mg twice daily
Treatment: Drugs: Clofazimine
Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if <40kg or 100mg if =40kg once daily.
Treatment: Drugs: Ethambutol
Adults: with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at either 15 mg/kg once daily or 25mg/kg thrice weekly. Children with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at 20 mg/kg once daily.
Treatment: Drugs: Amikacin
adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily
Treatment: Drugs: Linezolid
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral linezolid 600mg once daily.
Children: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Age 1 week - 9 years 10mg/kg twice daily maximum dose of 300mg. Age 10-12 years 10mg/kg twice daily maximum dose of 600mg. >12 years 600mg once daily.
Treatment: Drugs: co-trimoxazole
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP/kg maximum dose of 160mg TMP/ 800mg SMX twice daily.
Treatment: Drugs: Doxycycline
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages = 8 years) 2mg/kg once daily maximum dose 100mg.
Treatment: Drugs: Moxifloxacin
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg
Treatment: Drugs: Bedaquiline
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).
Treatment: Drugs: Rifabutin
Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg/kg once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Appendix A1 - MABS clearance from respiratory samples with tolerance at final outcome
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Assessment method [1]
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The probability of MABS clearance with good tolerance at final outcome. MABS clearance defined as: Negative MABS cultures from 4 consecutive sputum samples with one of those sputum specimens collected four weeks after the completion of consolidation therapy or a MABS negative BAL collected four weeks after completion of consolidation.
Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [1]
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56 weeks for participants who received short intensive therapy and 62 weeks for participants who received prolonged intensive therapy.
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Primary outcome [2]
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Nested Study A1.1 Short Intensive Therapy - MABS Clearance
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Assessment method [2]
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The number of patients in each group with microbiological clearance of MABS with good tolerance (in accordance with CTCAE). MABs clearance based on results from 3 sputum specimens or one BAL. Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [2]
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Samples collected at 4 weeks and culture results determined at 6 weeks
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Primary outcome [3]
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Nested study A1.1.1 Efficacy of inhaled Amikacin during intensive therapy in comparison to intravenous Amikacin in the treatment of MABS-PD
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Assessment method [3]
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The number of patients in each group with microbiological clearance of MABS with good tolerability at completion of short intensive therapy with the use of inhaled amikacin (Arm B) and with the use of IV amikacin (Arm A) given during intensive phase. Clearance will be based on results from 3 consecutive sputum or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [3]
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samples collected at 4 weeks and culture results determined at 6 weeks
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Primary outcome [4]
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Nested Study A1.1.2 Efficacy of additional clofazimine during short intensive therapy in comparison to no additional clofazimine for treatment of MABS-PD
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Assessment method [4]
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The number of patients in each group with microbiological clearance of MABS with good tolerability at completion of short intensive therapy with the use of additional clofazimine (Arm A) and without the use of additional clofazimine (Arm C) given during intensive phase. Clearance will be based on results from 3 consecutive sputum or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [4]
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samples collected at 4 weeks and culture results determined at 6 weeks
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Primary outcome [5]
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Nested Study A1.2 - Comparison of microbiological clearance of MABS with good tolerability at 12 weeks in patients with MABS positive cultures at 6 weeks and allocated to prolonged intensive therapy and those allocated to consolidation therapy.
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Assessment method [5]
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The number of patients in each group with clearance of MABS at 12 weeks with good tolerance. Clearance will be based on the results of 3 consecutive sputum samples or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [5]
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samples collected at 10 weeks and culture results determined at 12 weeks
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Primary outcome [6]
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Nested Study 1.3 Consolidation Therapy - Comparison of MABS clearance between those allocated to consolidation therapy with oral treatment and those allocated to consolidation with oral therapy and additional inhaled amikacin
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Assessment method [6]
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The number of patients with microbiological clearance of MABS with good tolerability between those allocated to consolidation therapy with oral treatment and those allocated to consolidation therapy with oral therapy and additional inhaled amikacin. MABS clearance based on 3 consecutive sputum samples or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
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Timepoint [6]
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52 weeks or 58 weeks depending on clearance of MABS at 4 weeks, with those allocated to short IT completing at 52 weeks and those allocated to prolonged IT completing at 58 weeks.
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Secondary outcome [1]
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The probability of microbiological clearance of MABS at time point final, irrespective of toxicity for participants according to treatment path.
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Assessment method [1]
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Probability of microbiological clearance irrespective of adverse event reporting.
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Timepoint [1]
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6 weeks, 12 weeks, at end of consolidation (52 and 58 weeks) and at final outcomes at 56 weeks and 62 weeks
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Secondary outcome [2]
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The safety of the treatment combinations in patients with MABS
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Assessment method [2]
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The number of participants with treatment-related adverse events as assessed by CTCAE version 5 at completion of short IT, at completion of prolonged IT, at completion of CT and at final outcomes.
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Timepoint [2]
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6 weeks and 12 weeks and at end of consolidation (52 and 58 weeks) and after trial has been completed
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Secondary outcome [3]
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The relative change in FEV1 z-score between treatment groups for time point final compared with time point start in patients who do and who do not clear MABS at time point final.
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Assessment method [3]
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Relative change in FEV1 z score compared between treatment groups
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Timepoint [3]
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Day 0, 6 weeks, 12 weeks, at end of consolidation (52 and 58 weeks) and at final outcomes at 56 weeks and 62 weeks
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Secondary outcome [4]
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Change in % Bronchiectasis scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
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Assessment method [4]
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Change in % Bronchiectasis using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
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Timepoint [4]
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Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
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Secondary outcome [5]
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Change in % Air Trapping scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
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Assessment method [5]
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Change in % Trapped Air using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
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Timepoint [5]
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Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
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Secondary outcome [6]
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Change in % Disease scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
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Assessment method [6]
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Change in % Disease using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
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Timepoint [6]
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Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
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Secondary outcome [7]
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The predictive value of structural abnormalities at Day 0 (screening) CTs for sputum conversion and for progression of structural changes in relation to therapy.
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Assessment method [7]
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Association between structural abnormalities (%Bronchiectasis, %Air trapping and %Disease) at screening Day 0 and clearance of MABs at 12 weeks and at final outcome and with change in %Bronchiectasis, %Air trapping and %Disease between screening day 0 and at 12 weeks and at final outcome
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Timepoint [7]
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Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
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Secondary outcome [8]
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The change in CFQ-R respiratory domain for those with CF between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
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Assessment method [8]
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The change in CFQ-R respiratory domain for patients with CF between baseline and at 6 weeks, 12 weeks and 56 weeks for those that had short intensive therapy and 62 weeks for those who received prolonged intensive therapy
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Timepoint [8]
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Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
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Secondary outcome [9]
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The change in HRQOL in adults, between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
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Assessment method [9]
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Change in HRQOL measured using the SF36
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Timepoint [9]
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Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
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Secondary outcome [10]
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The change in HRQoL in Children between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
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Assessment method [10]
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Change in HRQOL measured using the Peds-QL™
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Timepoint [10]
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Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
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Secondary outcome [11]
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The cost effectiveness of the proposed treatment combinations across both intensive and consolidation phases of the trial.
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Assessment method [11]
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Total cost between treatments calculated as the sum product of health resource utilisation and resource unit price during treatment period.
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Timepoint [11]
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from date of randomization for the duration of treatment up to 56 weeks for those allocated to short IT and up to 62 weeks for those allocated to prolonged IT
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Secondary outcome [12]
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The change in six minute walk distance for adult participants from the date of randomization to up to 62 weeks according to treatment path and in participants who do and do not clear MABS at time point final.
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Assessment method [12]
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Change in 6 minute walk distance using the six minute walk test in adult participants
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Timepoint [12]
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from date of randomization for the duration of treatment up to 56 weeks for those allocated to short IT and up to 62 weeks for those allocated to prolonged IT
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Eligibility
Key inclusion criteria
Intervention Cohort
- Subjects with respiratory cultures positive for M. abscessus (MABS) (sub species
abscessus, sub species bolletii, or subspecies massiliense) are required to meet all 3
American Thoracic Society criteria (clinical, radiological and microbiological) for
MABS pulmonary disease (PD).
- Subjects with mixed NTM infections (slow growers + MABS) (adding ethambutol will be
permitted if required by the treating physician).
- Willingness and ability to comply with trial regimens and the study visit
requirements.
Intervention cohort
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Receiving active treatment for MABS within the previous 12 months, except azithromycin
for participants with cystic fibrosis and bronchiectasis.
- Healthy volunteers may not participate.
- Pregnancy or planning to continue breastfeeding
- Known hypersensitivity to any of the therapies for which no alternate options(s) have
been provided.
Observation Cohort Inclusion Criteria:
- At least one positive respiratory MABS culture
- Willingness and ability to comply with the study visit requirements.
Observation cohort Exclusion Criteria for:
- Receiving active treatment for MABS within the previous 12 months, except azithromycin
for participants with cystic fibrosis and bronchiectasis.
- Healthy volunteers may not participate.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2024
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [5]
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Cairns Base Hospital - Cairns
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Recruitment hospital [6]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [7]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [8]
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Monash Children's Hospital - Clayton
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Recruitment hospital [9]
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Monash Medical Centre - Clayton
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Recruitment hospital [10]
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Concord Repatriation Hospital - Concord
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Recruitment hospital [11]
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Gladstone Hospital - Gladstone
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Recruitment hospital [12]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [13]
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Greenslopes Private Hospital, - Greenslopes
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Recruitment hospital [14]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [15]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [16]
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Mackay base Hospital - Mackay
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Recruitment hospital [17]
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Sir Charles Gardiner Hospital - Nedlands
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Recruitment hospital [18]
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John Hunter Hospital - New Lambton
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Recruitment hospital [19]
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Perth Children's Hospital - Perth
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Recruitment hospital [20]
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The Alfred - Prahran
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Recruitment hospital [21]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [22]
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Rockhampton Hospital - Rockhampton
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Recruitment hospital [23]
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [24]
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Townsville Hospital - Townsville
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Recruitment hospital [25]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [26]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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- Woolloongabba
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Birtinya
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Recruitment postcode(s) [5]
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- Cairns
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Recruitment postcode(s) [6]
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- Camperdown
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Recruitment postcode(s) [7]
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- Chermside
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Recruitment postcode(s) [8]
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- Clayton
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Recruitment postcode(s) [9]
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- Concord
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Recruitment postcode(s) [10]
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- Gladstone
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Recruitment postcode(s) [11]
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- Gold Coast
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Recruitment postcode(s) [12]
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- Greenslopes
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Recruitment postcode(s) [13]
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- Herston
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Recruitment postcode(s) [14]
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- Hobart
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Recruitment postcode(s) [15]
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- Mackay
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Recruitment postcode(s) [16]
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- Nedlands
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Recruitment postcode(s) [17]
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- New Lambton
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Recruitment postcode(s) [18]
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- Perth
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Recruitment postcode(s) [19]
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- Prahran
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Recruitment postcode(s) [20]
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- Randwick
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Recruitment postcode(s) [21]
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- Rockhampton
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Recruitment postcode(s) [22]
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- South Brisbane
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Recruitment postcode(s) [23]
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- Townsville
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Recruitment postcode(s) [24]
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- Westmead
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Toronto
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Denmark
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Aarhus
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Singapore
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London
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United Kingdom
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Nottingham
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Funding & Sponsors
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The University of Queensland
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Other
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Australian Government Department of Health and Ageing
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Other
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Children's Hospital Foundation
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Other
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Cystic Fibrosis Foundation
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Other
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Newcastle University
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Griffith University
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Erasmus Medical Center
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Monash University
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University of Copenhagen
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Other
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Hôpital Cochin
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South Australian Health and Medical Research Institute
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University of Melbourne
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James Cook University, Queensland, Australia
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Murdoch Childrens Research Institute
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Ethics approval
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Summary
Brief summary
Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant
non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease
(MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated
lung function decline, impaired quality of life, more challenging lung transplantation, and
increased mortality. While the overall numbers affected is small, the prevalence of
infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium
abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best
treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as
well as developing biomarkers (serology, gene expression signatures, and radiology) to guide
decisions for starting treatment and measuring disease severity in patients with MABS PD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04310930
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Claire Wainwright, MD
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+61730697322
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04310930
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